The incidence of trauma to newly amputated limbs is significant and can be debilitating. This population is primarily the diabetic, dysvascular and/or patients otherwise in generally poor health. These patients are at great risk of falling and of delayed wound healing. They may never become prosthetic candidates, particularly if they fall onto their residual limb and re-open the surgical wound.
Prior devices for post operative application include:                a) U.S. Pat. No. 5,211,667, issued to Michael Danford, shows a prosthesis for protecting a residual limb. The device comprises an upper shell lined with a soft material contoured to match the residual limb and a lower shell telescoping over the upper shell. The assembly includes slots through both shells to receive an elongated strap on the end of the sock covering the stump and fasteners on the external surface of the lower shell for attachment of the strap to the lower shell. Danforth prosthetics of Florida (now Otto Bock) offers the Danforth D-Pass stump protector, believed to be the device shown in the '667 patent. This product includes a molded thermoplastic exterior shell. It is available in both left and right version, that are not interchangeable, and 7-10 sizes of each are required to meet the needs of the variety of patients. It is not provided with a waist belt suspension system nor does it include a reticulated end pad for cushioning the surgical wound.        b) Non-Weight bearing dressings—WU dressing or non-weight bearing removable rigid dressings (“removable” applies to a specific casting technique and does not refer to a device which can be reapplied after removal) is a cast application technique, not a commercially available product. These are primarily casts that are applied directly to the residual limb. Casting material, readily available in most medical facilities, provides a rigid shell. However it can be tricky to apply in a manner that will prevent pressure sores on bony prominences. They are not easily removable for wound and dressing changes. If they are removed or inadvertently slide off, re-application can cause wound trauma. Skilled operators are also required for the application of these devices so that a tourniquet effect is not created proximally. Additionally, they can not be readily post-formed to accommodate change or to make adjustments. There is also a risk of skin breakdown when a cast-like removable rigid dressing is used.        c) Flo-tech manufactures a knee extension, post amputation protective device known as APPOPS for postoperative knee immobilization. This device indicates it is covered by U.S. Pat. Nos. 5,571,209 and 5,728,165 issued to Robert Brown and assigned to Flo-Tech Orthotic & Prosthetic Systems. These patents show a post operative protective socket for transtibial amputees. The device labeling includes a single piece semi-rigid plastic structure, which includes a cup-shaped base, into which the stump is placed, with the plastic structure partially surrounding the limb above the amputation site. Circumferential cuffs are attached to the rear surface of the shell for securing the hard shell to the stump. Because of its construction, multiple sizes are required for different patients and different assemblies are required for left or right application. It is also indicated that it can be used prior to progression into a weight bearing prosthetic system.        